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Table of Contents
Summary of Contents for Gold Standard ThunderBolt
- Page 1 ® ThunderBolt User’s Manual 1. ...
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Page 2: Table Of Contents
2.4. Biological Safety .......................... 4 2.5. Safety Labels .......................... 4 3. System Description ........................ 5 3.1. System ............................ 5 3.2. System Details .......................... 5 3.3. Component Details ........................ 6 4. ThunderBolt Software ........................ 7 4.1. Instrument Graphical User Interface (GUI) ................... 8 4.2. Other Software Applications ...................... 9 5. Running a Worklist ........................ 10 5.1. Worklist Preparation ........................ 10 5.2. Samples Tab .......................... 11 5.3. Microtiter Plates Tab ........................ 13 ... -
Page 3: Introduction
The ThunderBolt is designed and manufactured in accordance with the safety requirements for electronic and medical systems listed in the certifications section above to ensure that the instrument functions safely, both electrically and mechanically under normal use conditions. The ThunderBolt is supplied in a condition that allows for safe and reliable operation. 2.1. General Safety The ThunderBolt must only be operated in accordance with the stated intended use. It is recommended that the ThunderBolt is used only with the spare parts and accessories suggested or provided by Gold Standard Diagnostics. The use and maintenance activities defined in this manual are intended to ensure the safety of the operator and the proper functionality of the instrument. All system surfaces must be dry while operating the ThunderBolt. Gold Standard Diagnostics TB‐0001.I ... -
Page 4: Electrical Safety
This should be done cautiously and only when absolutely necessary. 2.4. Biological Safety Any parts of the ThunderBolt that have come into contact with samples/test reagents are to be treated as being potentially infectious. Some of the general purpose reagents have the potential to cause irritation of the skin and mucous membranes. It is recommended that the operator use appropriate personal protective equipment (PPE) such as gloves, lab coat, and eye protection while ... -
Page 5: System Description
Instrument Power Specifications Voltage: 100 – 265 V Frequency: 50 – 60 Hz Power Consumption: 12W without incubator, 120W max It is recommended that the instrument be operated off of a dedicated power source. Ideally the ThunderBolt should be placed near an outlet and connected to a surge protector or an uninterruptable power supply (UPS). Instrument Dimensions and Weight Width: 64 cm (25.2 in) Depth: 57 cm (22.4 in) ... -
Page 6: Component Details
The fully integrated barcode scanner supports the following barcode types: codabar, code39, interleaved 2 of 5, code 93, code 2 of 5, IATA code 2 of 5, matrix 2 of 5, code 11, code 128, telepen, UPC A, UPC E, EAN 13, EAN 8, MSI, Plessey, RSS‐14, RSS‐14 Limited, RSS‐14 Expanded, China Post Code, and PDF417. Incubator The forced convection incubator heats to a maximum of 45°C. Reader The ThunderBolt’s on‐board reader is an ultra‐compact, fully integrated LED spectrophotometer which contains the standard wavelengths of 405, 450, 490, 550 and 630 nm. Custom wavelengths are also available. TB‐0001.I Page 6 of 31 ... -
Page 7: Thunderbolt Software
Photometric range: 0 to 3.0 OD Spectral range: 400 nm to 700 nm Read time: approx. 2min/plate Precision: 0 to 2.000 OD: +‐0.003 OD or CV < 1%, 2.001 OD to 3.000 OD: CV < 1.5% Resolution: 0.001 OD Linearity: < 1% 0 to 2.000 OD (typical), < 2% 2.001 OD to 3.000 OD ThunderBolt instruments equipped with the chemiluminescence option also contain a chemiluminescence reader and can handle both EIA and CLIA assays. Detection Type: glow Spectral Range: 300nm‐500nm Dark Count: 50 counts per second (standard) Measuring time: 100ms (adjustable 100‐1000ms) Dynamic range: 6 decades (orders of magnitude) Orbital Shaker The integrated orbital shaker features a no‐spill design which closely replicates manual shaking. The ThunderBolt can dispense and/or incubate while the shaker is in motion. Amplitude: 1 mm Adjustable speed: up to 900 RPMs Capacity: 3 MTP (2 reaction, 1 predilution) Voltage: 24 V Netbook PC The included netbook PC is attached to the instrument via a USB connection. The PC also contains ethernet, RS232, and additional USB ports. PC Minimum requirements are listed below: Processor: 1 GHz 32‐bit (x86) or 64‐bit (x64) Memory (RAM): 1 GB (32‐bit) or 2 GB (64‐bit) Memory (hard disk): 20 GB available (32‐bit) or 24 GB available (64‐bit) Ports: USB 2.0 (RS232, Ethernet ports optional) Integrated monitor: DirectX 9 graphics device with WDDM 1.0 driver, 800x600 resolution Software The pre‐installed EIA/CLIA Graphical User Interface software runs on the Windows based Netbook device included with the instrument. The software provides the ability to create and run worklists, ... -
Page 8: Instrument Graphical User Interface (Gui)
5. Report Templates: Any custom report templates (if applicable) are stored in the Report Templates subfolder. GUI Initialization 1. Verify that computer with installed GUI is attached to the ThunderBolt instrument, power is connected to instrument and to computer, and instrument power button is in the on position. Turn on computer and click the GUI icon (if GUI does not initialize automatically at computer startup) to initialize the system. 2. Wait for the ThunderBolt to initialize. The instrument requires approximately 30 seconds to ... -
Page 9: Other Software Applications
4. Racks: Allows the user to enable the Reagent Loading Wizard, (a window which prompts the user to check the volume of each reagent before starting a worklist), enable/disable intelligent rack and tube detection, and set reagent rack’s (and intelligent racks’, if applicable) size/definition. 5. Reports: Allows user to select custom laboratory information and logo for worklist reports. Options for custom report templates are also available. Default report template and GSD logo will be used on worklist reports if no changes are made. Contact local ThunderBolt distributor if additional information about custom report options is required. 6. LIS Communication: LIS connection options are set here (described in further detail in the LIS Configuration section of this manual). 7. LIS Test Mappings: Assigning of LIS test IDs to instrument test names is performed here (described ... -
Page 10: Running A Worklist
If the instrument has been moved, probe‐related maintenance has been performed, or if different‐sized racks have been placed on the instrument since the previous alignment, also perform instrument alignment prior to use. 2. Check Settings: Be sure to adjust/view the GUI Settings (described in ThunderBolt Software section above) as necessary prior to running the instrument. 3. Prepare Kit: It is essential that all package insert instructions for reagent handling and storage are ... -
Page 11: Samples Tab
Multiple Tests: Multiple tests can be added if settings are compatible; only compatible tests will be available in the Add Tests drop down menu once the first test file has been chosen. c. Test Files: New assays can be added to the Add Test drop down menu by copying and pasting the test files into the Tests folder within the ThunderBolt EIA documents folder before launching the GUI software. d. Remove Test: Any added test can be removed from the worklist by selecting it in the Remove Test drop down list. 2. Add samples: Click the Add Samples button. The Add Samples window will appear in the ... - Page 12 Follow the detailed instructions for sample placement as included in the Add Samples window for each Sample Entry Method while adding samples. Important Notes: Intelligent Racks: If intelligent rack tube detection is enabled, samples can be placed in any desired locations in the sample racks. If intelligent rack tube detection is not enabled, samples must be placed in the designated blinking positions. The Preloaded Sample Rack option can only be used when intelligent rack detection is disabled. Tube Placement: While placing samples, verify that samples are recognized (spaces with loaded samples display yellow or blue; unoccupied spaces will remain white or grey). If sample tubes are removed prior to starting the worklist (and intelligent rack tube detection is enabled), they will be removed from the worklist, and their identification will be lost. To be included in the worklist, they must be added again using one of the Sample Entry Methods described below. Sample IDs: Sample IDs cannot be edited after placement. To edit a sample ID, remove the sample from the worklist and add it again with a new ID. Duplicate sample IDs are not permitted; a suffix will be added to the sample ID if a sample with a duplicate ID is added. Sample Entry Methods: a. Manual: Use for non‐barcoded samples with custom IDs. Type the sample ID into designated field and click Add (or press Enter on the netbook keyboard). Place the sample in the rack as prompted and repeat for all manually‐labeled samples. b. Auto Increment: Use for Auto‐numbered samples. Change the Sample ID Template and Start Number if desired and click Add. Place samples in the sample rack, one by one as prompted. Samples will automatically be numbered consecutively, beginning with Sample #1 and continuing with Sample #2, #3, #4 etc. (according to ID Template and Start Number). c.
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Page 13: Microtiter Plates Tab
When all samples have been added, click Done to exit the Add Samples window. Display will return to the Samples tab. 3. Additional Sample Tab Options (optional): Click on the sample name to select sample(s) (selection is highlighted). Use the CTRL and SHIFT keys to highlight multiple samples. a. Remove Samples: Click this button to remove highlighted sample(s). b. Multiply Samples: Click this button to change the replicate of highlighted sample(s). Use the + and – buttons to adjust the indicated sample multiplication. c. Drag and Drop: Samples will be pipetted in the order listed on the Samples tab. Drag and drop samples to adjust processing order as desired. 4. Query LIS (optional): If LIS‐prompted sample selection is desired and LIS connectivity has been correctly configured, click the Query LIS button at this time. LIS will select appropriate samples for the chosen test(s) in the worklist. 5. Select Samples: If LIS‐prompted sample selection is not used, click on the box(es) next to the samples to select them for test(s). Check marks appear to indicate selection. a. Multiple samples can be selected for a test simultaneously by highlighting multiple samples, then clicking a box next to a sample to select all highlighted samples for a test. b. To select all samples for a test, right click on the desired test name at the top of the column. All samples in the test column will be selected. c. If the same testfile is run twice in the same worklist, Use the Smart Fill Tests button to fill all available sample positions on the first testfile and select remaining samples to run in the second testfile automatically. Following is an example of a Samples tab that has been properly prepared for a worklist run: Note: Rack Position is indicated for each sample (rack #: tube position #). 5.3. Microtiter Plates Tab This tab is used to determine the number of wells/strips/plates required for the run by displaying all well locations on the two microtiter plates (MTP) and the predilution plate. Additional information about each well is displayed on the screen when mouse cursor is placed over the well. This tab also includes predilution plate options. The following steps are taken to complete this tab: 1. Verification: Visually verify that all desired test wells and samples appear on the MTP layout in the correct plate locations. ... -
Page 14: Racks Tab
5.4. Racks Tab This tab displays the reagent rack and sample racks and is used to load reagents, calibrators, and controls, and to verify sample placement. Additional information about each position can be seen by hovering the mouse over the desired location. The following steps are taken to complete this tab: 1. Reagents: Load reagents into the ThunderBolt reagent rack using appropriately sized reagent adapters and following the colors/descriptions indicated. a. Be sure the notched edge of each reagent adapter is facing forward. b. When a worklist is started, the Reagent Loading Wizard will also guide the user through the process of adding reagents (if wizard is enabled in the GUI Settings). ... - Page 15 a. Use the Special Start button to start the worklist from a stopped/aborted position, from a specific step of the selected testfile(s), or to reread the plate(s) (plates can only be reread if worklist has already been run). 6. Check: Check required reagent and calibrator/control volumes as prompted by the Reagent Loading Wizard (if wizard is enabled). If multiple bottles of a single reagent are required to accommodate the indicated volume, use the Split Bottle option within the wizard window to load additional bottle(s). A split bottle can also be removed if desired, using the Remove Split Bottle button. 7. Run: Close the lid as prompted and wait for tests to run. Worklist actions can be monitored throughout the run using the log file and the live camera feed. The bar at the bottom of the screen ...
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Page 16: Tools Tab
Tools 1. Home Instrument: Use this button to “home” the instrument, just as is done automatically at GUI startup. 2. Park Instrument: Use this button to reset the ThunderBolt back to its starting, or “parked” position (with the probe assembly above the wash cup). 3. Prime Instrument: In the pop up window, select desired wash bottle(s) and number of priming cycles and click Start. If both washes are selected, the set number of priming cycles will be ... -
Page 17: Alignment And Calibration
read using a cursor to highlight. CTRL and SHIFT buttons can also be used to highlight specific wells on either/both the left and right plate(s). Set the applicable options for the read type: 1. Manual Read Plate ODs: Set measurement wavelength and reference wavelength (optional). 2. Manual Read Plate RLUs: Set integration time. Label the read data using the comment field (optional). Click start. Measurements will appear on the screen as the plate is read. When read is complete, export readings using the Export to CSV button or print using the Print button. Note: Manual readings are NOT saved automatically by the software. 6.3. Alignment and Calibration These instructions are intended to provide an overview of these functions; detailed step by step instructions are included in pop‐up windows within the instrument GUI when each function is performed. ... - Page 18 Instructions: Align Instrument: The user aligns the X and Y‐axis positions of the probe with the sample racks and microtiter plates. The Z‐axis position, which moves the probe up and down, is not manually aligned by the user: it is aligned automatically by the instrument during this procedure. 1. Click on the Align Instrument button. A pop up window will appear and provide instructions for each alignment step. 2. To align the probe at each position, use the buttons or keys to position the probe needles over the center of each location as prompted. Some example alignment positions are shown below: a. Wash cup alignment step: Align the probe to the middle of the wash cup, then move it down to verify that the probe can reach the bottom of the wash well without resistance. Proper alignment is shown here: Note: After the aligning the wash cup and clicking Next, the instrument will automatically calibrate the z‐sensor to the bottom of the wash cup. b. Sample tube alignment steps: Align the center of the probe needles to the center of the sample tube (X and Y axes). Proper alignment is shown here: 3. After completing all probe alignment positions, remove the Alignment Plates or MTPs as prompted, prior to continuing. Note: If these are not removed, the Z axis position cannot be properly set by the GUI. 4. At the final alignment step, ensure that the probe is centered above the left MTP carrier position, as prompted. The correct placement of the probe is shown below with the tip centered between four holes and roughly above the word “Hot” printed on the incubator surface: TB‐0001.I ...
- Page 19 5. Click Finish when prompted to complete and save the alignment and exit the window (instrument will return to its home position). Instructions: Auto Align Instrument: After the user sets the starting position of the probe on the MTP carrier, the instrument aligns all axis positions (X, Y, and Z) automatically during this procedure. 1. Click on the Auto Align Instrument button. A pop up window will appear and provide instructions for each alignment step. 2. Align the probe needles to the edge of the MTP carrier as prompted. Y axis (front to back) position of the probe must be exactly above the rear carrier lip. X axis (left to right) and Z axis (up and down) positioning are not important at this step. Proper alignment is shown here: 3. Verify proper plate and plug positioning when prompted and allow the instrument to complete the rest of the alignment automatically (This step takes approximately 10‐15 minutes). 4. Click Finish when prompted to complete and save the alignment and exit the window (instrument will return to its home position). Align Reader The reader alignment process is performed to ensure that the reader is in the correct position for reading MTPs. It is recommended that the reader alignment be performed and recorded as a part of the routine instrument maintenance. General Information 1. Remove all microtiter plates and Alignment Plates from the MTP carrier prior to starting the reader alignment procedure. ...
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Page 20: Maintenance
It is recommended that the startup and shutdown steps be performed any time the instrument is idle for four or more hours to prevent build‐up in the fluidics lines. Startup 1. Ensure wash bottle(s) are properly connected to the ThunderBolt. 2. Prime the instrument using the wash buffer(s) that will be used for testing a minimum of 10 priming cycles per line. 3. Ensure that all wash buffers are within their expiration date prior to each use. ... -
Page 21: Weekly Maintenance
Shutdown 1. Prime the instrument using DI water a minimum of 50 priming cycles per line. 2. Ensure all instrument surfaces are clean and dry. 3. Remove any remaining reagents and samples from the ThunderBolt and close the lid. 4. Shut down the instrument by shutting down the attached computer. 5. Empty waste bottle. 7.2. Weekly Maintenance Weekly maintenance includes cleaning and alignment steps that are to be performed approximately every seven days. It is recommended that the same day of the week be used for consistency. Care should be taken to ensure that no excess liquid comes into contact with the instrument surfaces while cleaning. Cleaning should only be performed with the recommended reagents. Weekly Maintenance steps should be performed as follows: 1. Remove sample racks and inspect each one for cleanliness and damage. a. Use isopropyl alcohol to gently clean all sample racks. 2. Clean the sliding reagent tray deck with isopropyl alcohol. 3. Clean the outside of both probe needles by wiping them down gently with an alcohol wipe. 4. Perform instrument and reader alignments as described in further detail in the Alignment and Calibration section of this manual. 5. Decontaminate the instrument tubing by priming the instrument 20 priming cycles per line with Liquinox solution. Note: The Liquinox solution is prepared by making a 1:100 dilution of the Liquinox Concentrate supplied with the instrument, using DI water. 6. Rinse the tubing by priming the instrument 50 priming cycles per line with DI Water. 7. It is recommended that wash bottles be cleaned weekly to avoid contamination. 7.3. Monthly Maintenance ... -
Page 22: Periodic Maintenance
8. If the liquid level fluctuates significantly or the cup fills with liquid in the two previous steps, readjust tubing and monitor priming again. If problem persists, contact technical service. 7.4. Periodic Maintenance Approximately every year (time will vary depending on instrument usage) a professional maintenance procedure should be performed by a trained service engineer. Service agreements are typically laboratory‐dependent and established to meet the specific needs of each client. Contact the local ThunderBolt distributor for more information. 7.5. Storage, Transportation, and Disposal Storage, transportation, and disposal of the ThunderBolt must be completed by a trained technician. A complete reinstallation must be performed following any move or storage of the instrument. The recommended storage and transportation conditions for the instrument should be similar to the use conditions. If the instrument is moved from its installed location or removed from service for an ... -
Page 23: Laboratory Information System Integration
8. Laboratory Information System Integration The LIS implementation of the ThunderBolt completely conforms to the NCCLS LIS2‐A2 and NCCLS LIS01‐ A2 (formerly known as ASTM E1394‐91 and ASTM E1381‐91) specifications. The ThunderBolt can communicate successfully with LIS systems that also conform to these specifications. Please be aware that some LIS companies will need to create special drivers before they will be able to be integrated with the ThunderBolt. In addition to the TCP‐IP implementation of NCCLS LIS01‐A2, the software also supports a “clean” TCP‐IP transmission. In this mode the software will send the unmodified NCCLS LIS2‐A2 frames including the <CR> at the end of the frame. No checksum or control characters are added. All LIS Settings are found within the LIS Communication and LIS Testname Mappings sections of the GUI Settings. LIS is queried from the Samples tab during worklist setup and results are sent to the LIS from the Worklist tab after run is complete. 8.1. LIS Records Data is sent to the LIS according to the following: Header Record: All communications begin with the header record. In the “Sender Name or ID” field, the name of the software and the version are displayed. Example: H|\^&|||Thunderbolt EIA^0.42.0.73|||||||P|LIS2‐A2|20101022162157 Request Information Record Specifics: The software will query the LIS system using “Request Information Records”. The field used to transmit the Sample ID to the LIS is the “Starting Range ID Number” field. In this field the first component is used: “Patient ID” Example: Q|1|S001^^||ALL In this example, the Sample ID is “S001” Patient Information Record: The LIS system will respond to the software using “Patient Information Records”. In the “Laboratory Assigned Patient ID” field the Sample ID is stored. Example: P|1||S001|| In this example, the Sample ID is “S001” Test Order Record: The LIS system will give specific Patient/Test information using “Test Order Records”. In the “Specimen ID” field the Sample ID is stored. From the “Universal Test ID” field the “Manufacturer defined test code” component is used to store the test information. This can be defined by the lab; a lookup table is used to match those codes to the real test names. Example: O|1|S004||^^^CMVIgG|R In this example, the Sample ID is “S004”, the test name is “CMVIgG”. Result Record: The instrument will send the results of patients back to the LIS using “Result Records”. In the “Data or Measurement Value” field, the numerical result of a patient is stored. ... -
Page 24: Lis Query And Transmission Examples
Examples: R|1|^^^CMVIgG|1.33|ng/ml||||F R|1|^^^CMVIgG|1.33^high|ng/ml||||F R|1|^^^CMVIgG^Subtest1|1.33|ng/ml||||F 8.2. LIS Query and Transmission Examples Example 1: Query of sample IDs Instrument LIS H|\^&|||Thunderbolt EIA^0.42.0.73|||||||P|LIS2‐A2|20101022162157 Q|1|S001^^||ALL Q|2|S002^^||ALL Q|3|S004^^||ALL L|1|N LIS Instrument H|\^&|||LIS|||||||P|LIS2‐A2|20101022162157 P|1||S001 O|1|S001||^^^CMVIgG|R P|2||S002 O|1|S002||^^^CMVIgG|R O|2|S002||^^^HPLIgG|R P|3||S004 O|1|S004||^^^CMVIgG|R O|2|S004||^^^HPLIgG|R L|1|N Example 2: Transmission of results Instrument LIS H|\^&|||Thunderbolt EIA^0.42.0.73|||||||P|LIS2‐A2|20101022162157 P|1||S001 O|1|S001||^^^CMVIgG|R R|1|^^^CMVIgG|1.33|ng/ml||||F L|1|N Example 3: Transmission of multiple test results per patient Instrument LIS H|\^&|||Thunderbolt EIA^0.42.0.73|||||||P|LIS2‐A2|20101022162157 P|1||S001 O|1|S001||^^^CMVIgG|R R|1|^^^CMVIgG|1.33|ng/ml||||F ... -
Page 25: Lis Configuration
P|1||S001 O|1|S001||^^^CMVIgG|R R|1|^^^CMVIgG^ST1|1.33|ng/ml||||F R|2|^^^CMVIgG^ST2|1.24|ng/ml||||F L|1|N 8.3. LIS Configuration 1. Verify that instrument is correctly installed and all power correctly connected to instrument and netbook. a. Verify that tests have been added to the Tests folder of instrument netbook. 2. Ensure that all relevant cords and cables for LIS system are connected to the instrument. a. TCPIP: Ethernet cord; RS232: serial cord 3. Select correct settings within the GUI software LIS Communication section. These must be entered before any communication with LIS is attempted. Select appropriate settings according to LIS being used: a. In the RS‐232 Connection section, set the baud rate, data bits, parity, and stop bits of the port. b. In the TCP/IP Connection section, set the Server address and the Server port of the LIS TCP Server. i. The “Use Frame Pooling” option allows the system to put more than one ASTM message (for example a Header Record) into a TCP Packet. This can speed the transfer. ii. If the “Use LIS01‐A2 Encoding” option is used, the software will use a “telnet”‐ like system (same data as through the RS‐232 connection). 4. Assign LIS test IDs to instrument test file names within the GUI software settings in the LIS Test Mappings section. List all LIS names and corresponding test file names, being careful to copy codes exactly as they are used in the LIS system. a. -
Page 26: Rs-232 Pin Layout
8.4. RS‐232 Pin Layout TB‐0001.I Page 26 of 31 ... -
Page 27: Troubleshooting Guide
9. Troubleshooting Guide Issue Details User Action Instrument GUI Is "No Instrument Found" Check that power switch on the back of the software will not error displayed? instrument is turned on. Check that power cord is start up plugged into the instrument and the outlet. Check that USB cable from instrument to computer is secure at both ends. Try rebooting. If problem persists, contact technical service. Run will not start Does instrument display Check that MTP plate(s) and predilution plate is/are an MTP plate error? correctly loaded and seated securely. Check that sufficient wells are placed. Check positions of probe during instrument alignment. If misaligned, realign instrument and restart. Does instrument display a Prime 10x, lift probe briefly (1‐2sec) to check for clog error? steady dispense flow. If dispensing appears correct, restart run. If not, carefully use stylet to clean probe. Check if blue liquid detection light is functioning properly by placing a small tube of liquid beneath the needles. Blue light should go on when in liquid ... - Page 28 Issue Details User Action Run stops in the Is there an IO or Power off computer and instrument, unplug and middle of a read/write error message replug power and USB connections, and restart. worklist displayed? Load worklist and rerun from aborted position. If problem persists, contact technical service. Is the machine jammed Turn off machine, carefully remove plate and move during the read step? reader back, load worklist, place plate back in, start worklist from the read step. Is the probe assembly Make sure there are no obstructions to probe jammed? movement. Make sure probe tubing is zip‐tied to flat cable and not being caught anywhere. Is there a drop between Pause the worklist, wipe off any visible drops or needles error? clots, clean with an alcohol wipe. Resume worklist. When worklist finishes, carefully clean the probe with the stylet and perform Liquinox decontamination. Waste Bottle Are there bubbles or liquid Wipe connector and needles completely dry. If alarms during run on the waste sensor alarm persists, disable waste bottle alarm in needles or the white ...
- Page 29 Issue Details User Action Failed run (cont.) Do points on curve appear Check if physical positioning of calibrators and out of order on report? controls in sample rack matches Racks tab. If not, Do high and low controls contact technical service to produce a manual appear switched? report. If test is in duplicate: Do Contact technical service to produce a manual calibrator/control report, omitting the outlier control/calibrator replicates show large replicate(s) or use the Drop Bottles Option in the differences? Test Properties window. Does it appear that only a Check for sufficient volume and bubbles in single calibrator or control reagents/calibrators/controls. Rerun with sufficient is missing? volume, bubbles removed. Note: Even if no bubbles are observed at the end of the run, a bubble could have caused the problem and later popped. Do all OD values on report Check position of red light during reader alignment. appear elevated? ...
- Page 30 Issue Details User Action Flooded Run Is the flooding outside the Check positions of probe during instrument (cont.) wells on the MTP carrier? alignment. If misaligned, realign instrument and rerun worklist. Perform a manual shake to check if shaker homes properly at the end of the shake. Repeat manual shake several times to confirm. Check if there is a visible clog on the probe. Even if no visible clog is seen, carefully use stylet to clean both probe needles. Check that MTPs are correctly loaded and seated securely. Check that the correct number of wells are loaded in the MTP using the Microtiter Plates Tab. Need to reprint or Does user know which Retrieve data from the Worklist or Worklist Report find past data date the desired data was folders of the instrument netbook. run? Dripping Probe Is the dripping coming While priming the instrument, follow tubing at the Needles from the dispense needle? top of the probe and check for any droplets. ...
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Page 31: Contact Information
10. Contact Information 10.1. Device Manufacturer Company Name Gold Standard Diagnostics Company Address 2851 Spafford Street Davis, CA 95618 Country United States Phone 530‐759‐8000 Fax 530‐759‐8012 Website www.gsdx.us ThunderBolt® Catalog # 00300; 00300‐CL 10.2. Authorized Representative Company Name Emergo Europe Company Address Molenstraat 15 2513 BH, The Hague Country The Netherlands Phone +31 70.345.8570 Fax +31 70.346.7299 Website www.emergogroup.com TB‐0001.I ...
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